Foreign Affairs

The heparin debacle and other food and drug import scandals have generated considerable skepticism about industry reliance on imported drug ingredients—and on the FDA's ability to adequately monitor foreign drug manufacturing. Policymakers are blasting FDA for going after US tomato growers while Mexican peppers were the real culprit in this summer's salmonella outbreak. Allegations of manufacturing violations and fraud by Indian drugmaker Ranbaxy prompted the House Energy & Commerce Committee to question whether FDA took appropriate action to keep adulterated Ranbaxy drugs out of the United States. Moreover, the case has generated murmurs about another generic drug scandal—20 years after fraudulent activity rocked FDA and the then-nascent generic drug industry.

The good news from the foreign enforcement front is that Congress finally is giving FDA some additional resources to expand overseas inspections and oversight. The agency received a $150 million budget supplemental in June to boost food and drug inspections and enhance drug safety, and there's support on Capitol Hill for further increases in FDA's 2009 budget.

Legislators are also crafting laws to strengthen FDA's ability to block suspect imports and crack down on fraudulent operators. FDA agrees on the need for subpoena power, as well as authority to destroy unsafe products at the border, impose stiffer penalties for criminal acts and counterfeiting, and block imports from plants that refuse access to FDA inspectors. Congress might even give FDA a more realistic four-year cycle for inspecting manufacturing plants, instead of retaining the two-year requirement that it seldom meets.

But any FDA legislation moving through Congress next year is likely to go beyond a few agreed-upon improvements. Even though FDA is just barely digesting last year's massive FDA Amendments Act, another hefty reform bill may emerge that also curbs drug advertising and reorganizes how the agency evaluates and monitors drug safety; follow-on biologics could join the party. E&C chairman Rep. John Dingell (D-MI) and Sen. Edward Kennedy (D-MA), chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, have been crafting food and drug import legislation this year, while Sen. Chuck Grassley (R-IA) still wants to split FDA operations for approving new drugs from postmarket surveillance. One bone of contention is whether to levy new user fees on importers to finance expanded foreign inspections. Dingell wants the fees, but FDA fears an administrative nightmare.

Meanwhile, pharma companies are under the gun to better monitor foreign contractors and ensure the safety and quality of imported ingredients and products. Sen. Sherrod Brown (D-OH) wants to know whether drugmakers are expanding outsourcing largely to obtain cheaper, less stringently regulated imports at the expense of lost jobs and additional health risks for Americans. Brown has asked FDA to address this issue, and has queried Pfizer and Merck on the ramifications of their outsourcing programs. And if overseas operations do save money, Brown expects those cost reductions to translate into savings for US consumers.

Beyond Our Borders

Global enterprise

Everyone agrees that FDA's current system for monitoring foreign drug manufacturing—to say nothing of food imports—cannot cope with the surge in active ingredients and drug products imported from overseas. (See "Global Enterprise") Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), told the E&C Committee in May that inspections alone cannot fully evaluate if manufacturing facilities can produce safe, high-quality products. And we can no longer "inspect out" bad products at the border, said FDA deputy commissioner Murray Lumpkin at the Drug Information Association (DIA) annual meeting in June.